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Monoclonal Antibodies
Radium-223 + Pembrolizumab for Prostate Cancer
Phase 2
Waitlist Available
Led By Atish Choudhury, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed adenocarcinoma of the prostate
Metastatic disease by bone scan
Must not have
Prior treatment with radium-223 or PD-1/PD-L1/PD-L2 blocking therapy
Pathology consistent with majority of specimen having small cell carcinoma of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up imaging was performed every 12 weeks and up to 25 months.
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying the safety and tolerability of an investigational combination of drugs, radium-223 plus pembrolizumab, for the treatment of castration-resistant prostate cancer.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They must have had a biopsy confirming adenocarcinoma, show cancer progression, and have metastatic disease visible on bone scans. Participants need good organ function, an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and agree to use contraception.
What is being tested?
The trial is testing the combination of Radium-223 (a radioactive drug) with Pembrolizumab (an immunotherapy drug) for safety and effectiveness in treating castration-resistant prostate cancer that has spread to bones.
What are the potential side effects?
Possible side effects include fatigue, nausea, diarrhea, skin reactions at the injection site for pembrolizumab; radium-223 may cause nausea, diarrhea, vomiting and low blood cell counts which could lead to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer diagnosis was confirmed through a tissue examination.
Select...
My cancer has spread to my bones, confirmed by a scan.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously received treatment with radium-223 or PD-1/PD-L1/PD-L2 blockers.
Select...
My prostate cancer is mainly small cell type.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ imaging was performed every 12 weeks and up to 25 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~imaging was performed every 12 weeks and up to 25 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Increased Immune Cell Infiltration Across Arms
Secondary study objectives
Median Overall Survival
Median Progression-Free Survival
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Radium-223Experimental Treatment1 Intervention
- Radium-223 will be administered intravenously every 4 weeks at a pre-determined dose
Group II: Pembrolizumab Plus Radium-223Experimental Treatment2 Interventions
* Radium-223 will be administered intravenously every 4 weeks at a pre-determined dose
* Pembrolizumab will be administered intravenously every 3 weeks at a pre-determined dose
Radium-223 will be halted after 3 doses. Once radiographic progressive disease occurs, the last 3 doses of radium will be given.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radium-223
2023
Completed Phase 2
~100
Pembrolizumab
2017
Completed Phase 3
~3150
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,110 Previous Clinical Trials
358,253 Total Patients Enrolled
76 Trials studying Prostate Cancer
15,736 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,758 Total Patients Enrolled
27 Trials studying Prostate Cancer
17,449 Patients Enrolled for Prostate Cancer
Atish Choudhury, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer diagnosis was confirmed through a tissue examination.I have had multiple treatments for my condition.I am 18 years old or older.I meet the specific health and treatment history criteria for the study.My prostate cancer is resistant to hormone therapy and is getting worse.My cancer has spread to my bones, confirmed by a scan.I am fully active or can carry out light work.I am willing to have a bone biopsy before and during the study.My organs are functioning well.I have previously received treatment with radium-223 or PD-1/PD-L1/PD-L2 blockers.My prostate cancer is mainly small cell type.
Research Study Groups:
This trial has the following groups:- Group 1: Radium-223
- Group 2: Pembrolizumab Plus Radium-223
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.